Wood v. Wyeth-Ayerst Laboratories

• Decision Date: 22 August 2002
• Docket Number: No. 2000-SC-1067-DG.,2000-SC-1067-DG.
• Citation: 82 S.W.3d 849
• Parties: Erma Rae WOOD, on Behalf of Herself and All Others Similarly Situated, Appellants, v. WYETH-AYERST LABORATORIES, DIVISION OF AMERICAN HOME PRODUCTS; A.H. Robins Company, Appellees.
• Court: United States State Supreme Court — District of Kentucky

82 S.W.3d 849

Erma Rae WOOD, on Behalf of Herself and All Others Similarly Situated, Appellants, v. WYETH-AYERST LABORATORIES, DIVISION OF AMERICAN HOME PRODUCTS; A.H. Robins Company, Appellees.

No. 2000-SC-1067-DG.

Supreme Court of Kentucky.

August 22, 2002.

John R. Shelton, Parker & O'Connell, PLLC, Louisville, for Appellant.

William D. Grubbs, Jann B. Lodsdon, Kristin M. Lomond, David T. Schaefer, Richard H. Clay, Stephen D. Weisskopf, Woodward, Hobson & Fulton, Louisville, Victor E. Schwartz, Mark A. Behrens, Rochelle M. Tedesco, Shook, Hardy & Bacon LLP, Washington DC, Hugh F. Young Jr., Product Liability Advisory Council, Reston, VA, William Kennedy Simpson, Thompson, Miller & Simpson, Louisville, for Appellee.

GRAVES, Justice.

I.

In 1973, the United States Federal Food and Drug Administration approved the use and sale of fenfluramine, an appetite suppressing diet medication. The drug was tested, manufactured, and packaged by A.H. Robins and sold by Wyeth-Ayerst Laboratories, under the trade name Pondimin. Appellees, American Home Products Corporation (hereinafter referred to collectively as "AHPC"), of which Wyeth-Ayerst is a division, also marketed another FDA-approved medication for obesity containing fenfluramine, called Redux. Demand for fenfluramine soared during the mid-1990's, when people began using it along with phentermine in a diet drug combination known as "Fen-Phen." The FDA never approved this drug combination.

In response to reports linking fenfluramine consumption to an increased risk of heart valve regurgitation, and apparently under pressure from the FDA, AHPC withdrew both Pondimin and Redux from the market in September 1997. Since then, many medical studies have confirmed the relationship between fenfluramine use and heart valve abnormalities.

In November 1999, AHPC entered into a "Nationwide Class Action Settlement Agreement" to redress physical injuries of fenfluramine users and provide medical screening to detect health problems arising in others in the future. Appellant, Erma Rae Wood, and many others "opted out" of this settlement because it specifically excluded claims for primary pulmonary hypertension, an often fatal disease stemming from decreased blood flow between the heart and lungs. Appellant seeks relief instead in the immediate suit. She has filed a motion for class certification under CR 23, requesting designation of the suit as a class action with her as the class representative.

Appellant claims to have used the drug fenfluramine from June to December of 1996, and she alleges her exposure to the hazardous substance was the result of AHPC's negligence. In her complaint, Appellant, on behalf of a proposed class, seeks the following relief: (1) court-supervised notice and medical monitoring to enable people who have ingested Fen-Phen to be monitored for the existence of potentially dangerous side effects caused by the drugs, including, but not limited to, valvular heart disease, primary pulmonary hypertension, and for altered serotonin levels and associated cognitive and/or neurophysiological manifestations of impairment or injury; (2) a fund to pay for such monitoring and also medical research concerning the effects of the drugs; (3) reimbursement of the costs of the drugs and/or previously incurred examination costs; and (4) punitive damages. Appellant has advanced various theories of liability as bases for recovery, including negligence, strict liability, concert of action, and enterprise liability.

The trial court dismissed Appellant's complaint for failure to state a claim upon which relief can be granted, pursuant to CR 12.02. A motion for dismissal for failure to state a claim should only be granted if it appears the pleading party could not prove any set of facts in support of his claim that would entitle him to relief. Pari-Mutuel Clerks' Union of Kentucky, Local 541, SEIU, AFL-CIO v. Kentucky Jockey Club, Ky., 551 S.W.2d 801, 803 (1977). The trial court concluded that Kentucky law requires a plaintiff to prove some present physical injury to support a tort claim, and Appellant had proven no such injury. The Court of Appeals upheld the trial court's decision dismissing the case, also finding that Appellant did not allege in her complaint any "present physical harm as a result of her ingestion of Fen-Phen." Appellant then petitioned this Court for review. There being recent developments in toxic tort litigation in other states, we granted discretionary review to address the important issues raised by Appellant regarding prospective relief for past exposure.

Appellant's complaint specifies as her injury, and that of the class she seeks to represent, "significantly increased risk of serious injury and disease." She further claims that she and others will "probably . be required to pay sums to ascertain the existence, nature and extent of their injuries in the future." In support of her claim, Appellant cites to many articles from various medical journals in which experts have recommended ongoing diagnostic testing for people who took fenfluramine. Notwithstanding these expert opinions, recovery on a theory of tort, like negligence or strict liability as sought here, requires a plaintiff to show some present physical injury to support a cause of action. Appellant has offered no proof that she suffers from any injury at the present time resulting from her contact with or ingestion of fenfluramine. As such, Appellant has failed to state a claim upon which relief can be granted and her cause of action has not accrued. We therefore affirm the Court of Appeals in dismissing the complaint.

II.

This Court has consistently held that a cause of action in tort requires a present physical injury to the plaintiff. As early as Louisville & N.R. Co. v. Roberts, 207 Ky. 310, 269 S.W. 333, 334 (1925), and again in Kentucky Traction & Terminal Co. v. Roman's Guardian, 232 Ky. 285, 23 S.W.2d 272 (1929), our predecessor Court refused to grant recovery for fright without any physical impact to support a cause of action. Later, in Morgan v. Hightower's Adm'r., 291 Ky. 58, 163 S.W.2d 21 (1942), the Court declined to permit recovery for mental distress unaccompanied by physical harm, noting that "In a long and unbroken line of decisions this Court has held that [such] an action will not lie." More recently, the Court has maintained the same position:

A cause of action does not exist until the conduct causes injury that produces loss or damage. The action for negligence evolved chiefly out of the old commonlaw form of action on the case, and it has always retained the rule of that action, that proof of damage was an essential part of the plaintiff's case.

Saylor v. Hall, Ky., 497 S.W.2d 218, 225 (1973).

In addition to her negligence claim, Appellant seeks redress on a theory of strict liability. Just as a negligence claim must be supported by a resulting physical injury, so must a claim based on strict liability. The Kentucky Court of Appeals adopted the view of the Restatement when it held, "To prevail in an action based upon strict products liability, a plaintiff must establish: (1) that there is a `product,' which ... (5) results in physical harm to the user or consumer or his property." Radcliff Homes, Inc. v. Jackson, Ky.App., 766 S.W.2d 63, 68 (1989) (citing Restatement (Second) of Torts § 402A (1965)). We agree that this is a correct statement of the law.

In recent decades, the issue of present physical injury has intersected with an emerging family of tort cases based on exposure to toxic or otherwise harmful substances. The most significant of these cases, Capital Holding v. Bailey, Ky., 873 S.W.2d 187 (1994), analyzed a series of earlier decisions by this Court dealing with the question of whether a tort claim could stand without an injury to support it. Addressing specifically the question of whether mere contact with toxic or harmful substances gives rise to a cause of action in tort, the Capital Holding decision remained true to traditional tort law requirements, holding essentially that even where exposure and negligent conduct could be proven, a case must be dismissed if the plaintiff can prove no present physical injury. Because of the similarities between Capital Holding and the case before us, we join with the trial court and Court of Appeals in concluding that it is the governing precedent as to the issue at hand.

The facts surrounding Capital Holding v. Bailey, supra, are essentially as follows. Plaintiff Bailey had worked removing pipes and ducts which his employer/defendant allegedly knew to contain asbestos. According to Bailey, he went home each day covered in asbestos. Upon learning of his exposure, Bailey sought medical attention. Although his doctor determined, and eventually testified, that Bailey had an increased risk of developing disease in the future, he found also that Bailey had no present abnormality or manifestation of disease. Because Bailey was suing on traditional tort theories of negligence and outrageous conduct, his cause of action depended on an actual injury. Reaffirming a summary judgment against Bailey, we stated that "until such time as the plaintiff can prove some harmful result from the exposure ... his cause of action has yet to accrue." Id. at 195. Thus, this Court concluded that in the absence of any present injury, recovery was not appropriate.

The Capital Holding decision based its holding on three previous opinions of this Court: Louisville Trust Co. v. Johns-Manville Products, Ky., 580 S.W.2d 497 (1979); Deutsch v. Shein, Ky., 597 S.W.2d 141 (1980); and Davis v. Graviss, Ky., 672 S.W.2d 928 (1984). Although each of these cases dealt with different factual situations, together they represent the firm legal foundation upon which Capital Holding was established, and upon which we now build.

In Louisville Trust Co. v. Johns-Manville Products, supra, the plaintiff died from lung cancer as the result of exposure...